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A multi-faceted intervention to improve syphilis screening and management in pregnant women in Indonesia: the DUALIS (Dual) study

A multi-faceted intervention to improve syphilis screening and management in pregnant women in Indonesia: the DUALIS (Dual) study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15855579
Enrollment
50
Registered
2025-06-30
Start date
2026-03-01
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving syphilis screening and management in pregnant women Infections and Infestations

Interventions

The information from East Nusa Tenggara and Central Java will inform site selection and ensure balanced and buffered randomization of Puskesmas in a 1:1 ratio to either intervention or control (curren

Sponsors

Universitas Gadjah Mada
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Facility eligibility: Eligible Puskesmas must: 1.1. Serve a mean of at least 320 new pregnant women per year, with 1.2. A burden of syphilis in pregnancy above the national average 2. Individual eligibility: All women attending their first ANC visit at participating Puskesmas or its network of community and private midwives, will be eligible to participate.

Exclusion criteria

Exclusion criteria: Puskesmas participating in any interventions to promote syphilis detection and management

Design outcomes

Primary

MeasureTime frame
1. The proportion of women screened for syphilis during the first trimester is measured using secondary data reported in ANC registers and in the online surveillance systems at baseline, midline (6 months) and endline (12 months) 2. The proportion of women testing positive for syphilis who receive at least one dose of benzylpenicillin is measured using secondary data reported in ANC registers, in the online surveillance systems, and patient interviews, monthly including at endline (12 months)

Secondary

MeasureTime frame
1. The proportion of women with a positive syphilis test who are managed according to guidelines is measured using secondary data reported in ANC registers, and patient interviews at midpoint (6 months) and at endline (12 months). 2. The proportion of women testing positive for syphilis who complete treatment at least 30 days before delivery is measured using secondary data reported in ANC registers, and patient interviews at midpoint (6 months) and at endline (12 months). 3. The proportion of women testing positive with a birth plan at the time of delivery is measured using secondary data reported in ANC registers, and patient interviews at midpoint (6 months) and at endline (12 months). 4. Birth outcomes in women testing positive for syphilis, including spontaneous abortions, intrauterine fetal deaths, preterm birth or low birth weight, are measured using secondary data reported in ANC registers, and patient interviews at midpoint (6 months) and at endline (12 months). 5. The proportion of women tested for HIV in the first trimester is measured using secondary data reported in ANC registers, and patient interviews at midpoint (6 months) and at endline (12 months). 6. The proportion of women tested for HBV in the first trimester is measured using secondary data reported in ANC registers, and patient interviews at midpoint (6 months) and at endline (12 months). 7. The proportion of women tested for all three infections in the first trimester is measured using secondary data reported in ANC registers, and patient interviews at midpoint (6 months) and at endline (12 months). 8. The proportion of women tested for all three infections during pregnancy is measured using secondary data reported in ANC registers, and patient interviews at midpoint (6 months) and at endline (12 months). 9. The proportion of women testing positive for HIV who are started on ARV treatment within 2 weeks is measured using secondary data reported in ANC registers and patient interviews

Countries

Indonesia

Contacts

Public ContactAri;Tsitsi Probandari;Monera-Penduka

;

ari.probandari@staff.uns.ac.id;Tsitsi.Penduka@lshtm.ac.uk+62 274 547147;-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026